TARRYTOWN, N.Y. & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Jan 10, 2008 - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the action date for its review of the New Drug Application (NDA) for subcutaneous methylnaltrexone. The FDA's revised action date for methylnaltrexone, currently being reviewed for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care, is now April 30, 2008.
The FDA, in its review of this NDA, requested the results from a recently completed QT study of intravenous methylnaltrexone, which is being developed for the management of post-operative ileus (POI). This study, which was submitted to the FDA, reported that there was no evidence of an effect of methylnaltrexone on QT prolongation. The FDA recently notified Progenics that it needs the extended time to review fully this study.
"We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission," says Paul J. Maddon, M.D., Ph.D, Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year."
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